Wearable Device for Motivating Hand Use After Stroke

An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke

The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients

Study Overview

• Status: Completed
• Conditions: Cerebral Stroke
• Intervention / Treatment: Device: Manumeter

Detailed Description

In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 80 years of age
• Experienced one or multiple strokes at least six months previously
• Upper Extremity Fugl-Meyer Score < 60 out of 66
• Absence of moderate to severe upper limb pain (< 3 on the a 10 point visual-analog pain scale)
• Ability to understand the instructions to operate the device

Exclusion Criteria:

• 80 years of age and above
• Implanted pacemaker
• moderate to severe pain in affected arm
• severe tone in affected arm as measured on a standard clinical scale
• language problem that would prevent from properly understanding instructions
• currently pregnant
• difficulty in understanding or complying with the instructions given by the experimenter
• inability to perform the experimental task that will be studied

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manumeter with interactive feedback; Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.	Device: Manumeter; A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.
Experimental: Manumeter without interactive feedback; Study participants will receive an experimental manumeter but receive no feedback from the manumeter, and will be given the current standard-of-care for increasing upper extremity exercise booklet to perform at home.	Device: Manumeter; A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Blocks Test (BBT)	To measure unilateral gross manual dexterity	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test (ARAT)	To evaluate specific changes in arm function from handling objects differing in size, weight and shape	3 months
Fugl-Meyer Motor Assessment (FM)	To assess motor functioning, balance, joint functioning thru performance based movement	3 months
Motor Activity Log (MAL)	To evaluate self-reported functional use of the limb	3 months
Amount of upper extremity activity	To evaluate the daily amount of upper extremity activity by using the wearable sensor	3 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: David Reinkensmeyer, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NIH HS# 2017-4119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No